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The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 74 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women."
  • "The primary outcome is informed decisions about breast MRI at T1."
  • "The aim of this study is to evaluate whether the decision support intervention produces a clinically significant change in informed decisions about breast MRI."
  • "The main hypothesis is that participants receiving the decision support intervention will be more likely to make an informed decision about breast MRI v. participants receiving enhanced usual care."
  • "During intake interviews for new RLC patients, navigators will administer the NCI Breast Cancer Risk Assessment Tool (BCRAT) via phone, enter responses into the BCRAT website in real-time, calculate lifetime breast cancer risk, and document BCRAT results in RLC's HIPAA-compliant, web-based patient tracking platform (RIPPLE©)."
  • "The BCRAT provides estimated lifetime risk for breast cancer to inform use of breast MRI, and will be used to determine study eligibility."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a decision aid helps Black and Latina women at high risk for breast cancer make informed choices about breast MRI, a scan that takes pictures of the breast. Women will be assigned by chance to get a risk check and referral to a nurse practitioner, either with or without the decision aid. Researchers will check their decisions after 1 month.

The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and 18–74 years old.
  • Identify as Black, Latina, or both.
  • Have never had breast cancer.
  • Speak English or Spanish.
  • Had a normal mammogram (breast X-ray) in the past 12 months.
  • Have at least a 20% lifetime chance of breast cancer, based on the NCI Breast Cancer Risk Assessment Tool.

Who can't join

  • Younger than 18 or age 75 or older.
  • Pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * female * aged 18-74 years * self-identifying as Black and/or Latina * no personal history of breast cancer * English- or Spanish-speaking * having received a mammogram with normal results in the last 12 months * ≥20% lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT) Exclusion Criteria: * aged \<18 or ≥75 * pregnancy

Study sites (1)

DC